Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements

Recruiting now

Conditions studied: Echocardiography, Artificial Intelligence, Diagnostic Imaging

In brief

Transthoracic echocardiography is an essential imaging modality for the diagnosis and follow-up of cardiovascular diseases. Comprehensive echocardiographic assessment requires multiple quantitative measurements of cardiac structure and function, which are time-consuming and highly dependent on operator expertise. US2.AI (Us2.v1) is an artificial intelligence (deep learning)-based software designed to automatically analyze standard two-dimensional and Doppler echocardiographic DICOM video clips acquired from different ultrasound vendors. The software provides automated measurements of cardiac morphology and function, including chamber dimensions and volumes, left and right ventricular systolic and diastolic function, myocardial strain, and Doppler-derived parameters, generating a comprehensive echocardiographic report based on current international guideline recommendations. In addition, the software may assist in identifying echocardiographic features suggestive of several cardiovascular conditions, including heart failure, pulmonary hypertension, hypertrophic cardiomyopathy, cardiac amyloidosis, valvular heart disease, and ischemic cardiomyopathy.

Key facts

Study ID

NCT07738419

Run by

Centro Cardiologico Monzino

People needed

1157

Starts

2026-04-27

Expected to finish

2027-01-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older.
• Undergoing clinically indicated standard transthoracic echocardiography.
• Adequate echocardiographic image quality for automated and expert analysis.
• Written informed consent provided prior to study participation.

You may not qualify if…

• Age <18 years.
• Frequent and/or complex cardiac arrhythmias during echocardiographic examination.
• Suboptimal echocardiographic images.

Where it is running

• Centro Cardiologico Monzino, IRCCS — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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